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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Headache (1880); Visual Impairment (2138); Depression (2361)
Event Type  No Answer Provided  
Event Description
I had lasik done 6 months ago.The outcome has changed my life forever.I now have terrible night vision, which now includes huge starburst and glare.My eyes really aren't dry, so i guess i dodged that bullet.The worst thing about it is that fixing my night vision problems would now require a hard rigid lenses designed custom made for my eyes, which may not even fix my problems.Before i had perfect vision with contact lenses.What a terrible mistake i have made.I am only (b)(6) and now for the rest of my life i have to right this devastating condition.Why is lasik even legal, why was i not told directly by the doctors that my large pupil would cause poor night vision.I would give every dime to my name to get my old crappy eyes back that were fixed perfectly with contact lenses.I have considered suicide on several occasions.I have never ever been suicidal my entire life.I am now on antidepressants which i know is the only reason i am here today explaining my struggle.I can no longer enjoy my night outs with my friends, i can't go anywhere at night without a horrible headache from trying to see.I pray and pray that they will find a way to cure this condition.Please shut down lasik.
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Brand Name
Type of Device
MDR Report Key4024257
MDR Text Key21728698
Report NumberMW5037734
Device Sequence Number1
Product Code LZS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age22 YR